1. Field of the Invention
The present invention is broadly concerned with improved apparatus and methods for closure of wounds in the tissue of patients, and especially wounds attendant to endovascular interventions, such as percutaneous cardiac intervention (PCI,) wherein closure is defined as the time from removal of the catheter to ambulating the patient. More particularly, the invention is concerned with such apparatus and methods which employs a rigid wound-closing body adapted to be placed adjacent and along the length of the wound, together with a force-exerting assembly operable to create forces which generate relatively high pressures on the patient's skin and tissue adjacent the wound. In preferred forms, the rigid body has a three-dimensionally asymmetric lower force-transmitting surface so as to exert forces of different magnitudes at different locations along the force-transmitting surface. Also, the force-transmitting surface is preferably exerted substantially constantly and in a substantially time-invariant manner.
2. Description of the Prior Art
Endovascular interventions such as PCI are widely accepted as a practical treatment option for coronary artery disease. For example, femoral artery puncture is commonly used in endovascular diagnostic and interventional procedures. Alternately, access may be made via the right radial or brachial artery. Such procedures are now commonly performed on an out-patient basis. In the case of a femoral arterial intervention, a puncture wound is made with a cannula to create an oblique subcutaneous tract and a terminal arteriotomy, followed by placement of a sheath within the tract. A catheter is then threaded through the sheath and into the adjacent artery, so that access can be had to the coronary arteries. After the diagnosis or intervention is completed, the catheter is withdrawn, the sheath is removed, and steps must be taken to close the wound. Wound closure typically involves compression to control bleeding until hemostasis occurs. Ideally, wound closure serves to minimize blood loss, effect hemostasis, and render the patient ambulatory in a relatively short period of time.
Poorly executed wound closures may give rise to complications which are costly, increase hospital stays and affect morbidity. For example, inadequate hemostasis can lead to significant blood loss, patient discomfort, vessel occlusion, thrombosis, formation of arteriovenous fistula, and pseudoaneurysm requiring surgical intervention and/or steps to avoid infections. Complications at the access site due to arterial cannulation occur in 1%-5% of cases, but may be as high as 14% with some interventional procedures.
Traditionally, wound closure has been a manual operation where a physician or nurse used manual hand pressure, using either one or two hands. One-handed manual pressure is usually carried out over a period of 30 minutes with a time to ambulation (TTA) of 4-6 hours. Two-handed manual pressure (often referred to as the “gold standard” of wound closure) ideally achieves optimal wound closure. In this technique, the healthcare professional's left hand exerts a semi-occlusive pressure upstream (closer to the heart) of the arteriotomy to moderate blood pressure fluctuations and to reduce the mean blood pressure from the heart without denying blood flow downstream. The professional's right hand holds an occlusive pressure over the arteriotomy, tract, and insertion site. This is continued for a period of approximately 30 minutes. However, in actual practice, there are a number of significant problems. For example, manual pressure that is too firm does not allow sufficient clotting factors to accumulate at the arteriotomy. Moreover, manual pressure along the tract varies because the tips of the four fingers of the right hand are not flat. Even more important, the person exerting manual pressure can tire during the 30-minute holding time, or the fingers may move or may not be placed properly. The person may also temporarily stop the application of pressure to examine the wound, causing a disruption of the maturing clot. Finally, different body types present different manual pressure issues, e.g., if the panniculus intrudes on the person's left hand, pressure variations may be induced as the patient breathes and the panniculus moves. TTA for this two-handed procedure is again normally 4-6 hours.
Manual techniques can be supplemented with use of applied hemostasis adjuncts, which reduce the time to hemostasis (TTH) to 5-6 minutes, but do not lower TTA because there is no force on the arteriotomy after hemostasis is achieved. Manual pressure may also be supplemented with external devices, such as C-clamps or sand bags. These combined techniques have many of the same problems as straightforward manual pressure closures, and the external devices may be difficult to deploy on obese patients. Thus, while manual procedures are of long standing, they are deficient in that they can be tiring, require careful training, and represent inefficient use of the time of valuable medical personnel.
Other closure techniques involve use of an intra-arterial anchor giving a TTH of about five minutes and a TTA of about 2-3 hours. Drawbacks of these procedures include a maximum French size of 8 Fr and the fact that the anchor and collagen plug must be left in the body for up to 90 days. Suture-mediated intra-arterial anchor techniques have also been used, but these are deficient in that the sutures remain in the body until absorbed, and nonetheless require that the anchor and plug be left in the body for an extended period. Finally, intra-tract closure has been used where the arteriotomy is mechanically stretched and then “boomerangs” back to an 18-gauge needle diameter. In these procedures, a heparin-neutralizing drug is deployed within the wound tract, and manual pressure is still required to close the 18-gauge needle hole.
In recent years, new, larger interventional devices of up to 20 Fr are being used to perform tasks like operations within the heart itself. No existing closure device is indicated for these large interventions, and resort must be had to manual pressure or surgical techniques to close the large wounds.
In response to these problems, various specialized vascular closure devices (VCDs) have been proposed, such as the device disclosed in U.S. Pat. No. 5,307,811 and commercialized under the designation “FemoStop.” While these and other VCDs have achieved widespread use, no prior VCD has fully solved the problems inherent in wound closures. Dauerman et al. (J AM COLL CARDIOLL. 2007; 50 (17) Elsevier Science)—“Vascular Closure Devices: The Second Decade” described an ideal VCD:                The patient factors influencing closure success notwithstanding the “ideal” closure device remains to be developed. What would this device look like? 1) A single device capable of providing successful closure for all patient and success site anatomical variations; 2) an atraumatic device without a foreign body or vascular alteration of the femoral artery; and 3) a simple-to-use device with >95% procedural success and low cost.        
The prior art uses the terms “pressure” and “force” loosely. A person exerting force through small fingers would apply more pressure than a person exerting the same force with larger fingers. A further complication is that the heart is beating, making the pressure (sum of internal and external pressure) variable. What is critical is controlling blood flow. If there were no flow restriction, the arteriotomy would leak, resulting in a hematoma. If there were complete flow restriction, then the downstream extremities would be starved of oxygen and the arteriotomy would be starved of necessary clotting factors. Hence, the ideal VCD is one in which flow is restricted, but not excessively.
Accordingly, there is an unfulfilled need in the art for a simple-to-use VCD which closely mimics “gold standard” manual wound closure, has a complication rate of <1%, can be used on all types of patients, gives very low TTH and TTA values, and does not involve residual drugs, sutures, or anchoring devices.